- Results provide significant medical proof to red meat up ApolloBio’s future regulatory submission in China of VGX-3100, INOVIO’s DNA immunotherapy candidate
- ApolloBio’s new medical results additional spotlight the aptitude of INOVIO’s DNA remedy platform to take care of ailments attributable to infection with diversified traces of the human papillomavirus (HPV), eradicating or reducing the necessity for surgical interventions
PLYMOUTH MEETING, Pa., Would possibly well 21, 2026 /PRNewswire/ — INOVIO (NASDAQ: INO), a biotechnology firm centered on growing and commercializing DNA medicines to abet take care of and give protection to people from HPV-related ailments, cancer, and infectious ailments, these days launched that its partner for VGX-3100 in China, ApolloBio, launched definite topline results from its pivotal Piece 3 trial of VGX-3100, INOVIO’s investigational DNA immunotherapy being developed as a doable medication for cervical dysplasia. The trial efficiently met its predefined main efficacy endpoint and demonstrated an overall favorable safety and tolerability profile. ApolloBio plans to employ the outcomes from the witness to red meat up a future regulatory submission of VGX-3100 in China.
“We imagine these definite topline results for VGX-3100 reflect both the aptitude of our DNA remedy platform in HPV-related ailments and the energy of partnerships to approach revolutionary DNA immunotherapies,” stated Dr. Jacqueline Shea, INOVIO’s President and Chief Govt Officer. “We dwell up for these recordsdata being offered at upcoming world medical conferences and published in behold-reviewed publications. We also wait for future updates from ApolloBio as they work in opposition to submitting for doable regulatory approval of VGX-3100 in China.”
Per the terms of the ApolloBio Agreement, INOVIO is entitled to receive as a lot as an aggregate of $20.0 million, much less required earnings, withholding or other taxes, upon the success of specified milestones related to the regulatory approval of VGX-3100 in specified territories. In the match that VGX-3100 is current for advertising and marketing, INOVIO would per chance be entitled to receive royalty funds in accordance with a tiered share of annual receive gross sales.
About VGX-3100
VGX-3100 is an revolutionary therapeutic DNA vaccine developed for ailments related to excessive-risk human papillomavirus (HPV) forms 16 and 18. VGX-3100 is designed to elicit an antigen-particular, CD8+ T cell response to hobble persistent HPV 16/18 infection, thereby selling lesion regression and viral clearance.
INOVIO licensed VGX-3100 to ApolloBio in 2018 for Bigger China. ApolloBio’s first supposed indication for VGX-3100 is HPV-16/18-associated cervical dysplasia, with the aim of no doubt offering patients in China with a non-surgical therapeutic choice that may well presumably abet discontinue faraway from or decrease fertility-related risks related to in model surgical medication (corresponding to LEEP/conization), together with preterm birth and miscarriage. ApolloBio would per chance be advancing medical development in other HPV-related excessive-grade precancerous lesions, together with anal/perianal, vulvar, and vaginal disease.
About ApolloBio’s Piece 3 Trial with VGX-3100
The witness, sponsored by ApolloBio, is a multicenter, doable, randomized, double-blind, placebo-managed Piece 3 pivotal registrational medical trial for the medication of HPV-16/18-associated cervical excessive-grade squamous intraepithelial lesions (HSIL), or cervical dysplasia. The main endpoint turned into once the composite response price at Week 36, outlined as histopathologic regression of cervical disease to low-grade lesion (CIN1) or usual histology, alongside with clearance of HPV-16 and/or HPV-18 infection. The witness turned into once led by Most cancers Health center, Chinese language Academy of Scientific Sciences, with Professor Lingying Wu serving as the main main investigator. A total of 22 top-tier tertiary hospitals all one of the significant top ways by China participated within the trial.
ApolloBio launched that the trial efficiently met its predefined main efficacy endpoint and demonstrated an overall favorable safety and tolerability profile, and not using a new important safety risk indicators noticed. The definite of this witness presents significant medical proof to red meat up ApolloBio’s future regulatory submission of VGX-3100 in China.
About HPV, Cervical Most cancers, and Cervical Dysplasia
HPV is the commonest sexually transmitted infection and is the foremost motive behind cervical cancer, which is the fourth most total cancer in females globally with spherical 660,000 new conditions and 350,000 deaths in 2022. Two kinds of HPV (HPV 16 and HPV 18) collectively do of dwelling off about 70 p.c of cervical cancer conditions worldwide. Excessive-grade cervical dysplasia would per chance be attributable to persistent HPV infection and is a precancerous situation that may well development to cervical cancer if left untreated. For the time being there must not any US-current therapeutic treatments for persistent HPV infection or cervical dysplasia.
About INOVIO’s DNA Medicines Platform
INOVIO’s DNA medicines platform has two revolutionary substances: exactly designed DNA plasmids, delivered by INOVIO’s proprietary investigational medical instrument, CELLECTRA. INOVIO makes employ of proprietary know-how to plan its DNA plasmids, which may well presumably be shrimp spherical DNA molecules that work like instrument the physique’s cells can download to salvage particular proteins to rental and fight disease. INOVIO’s proprietary CELLECTRA supply units are designed to optimally insist its DNA medicines to the physique’s cells without requiring chemical adjuvants or lipid nanoparticles and without the danger of the anti-vector response historically considered with viral vector platforms.
About INOVIO
INOVIO is a biotechnology firm centered on growing and commercializing DNA medicines to abet take care of and give protection to people from HPV-related ailments, cancer, and infectious ailments. INOVIO’s know-how optimizes the plan and supply of revolutionary DNA medicines that educate the physique to fabricate its possess disease-combating instruments. For more recordsdata, focus on with www.inovio.com.
About ApolloBio
ApolloBio Corp. is a number one Chinese language biomedical firm committed to analysis and development of revolutionary new medicines, accessing such new medicines by in-licensing, and furthermore offering medical products and services. ApolloBio Corp. is centered on pharmaceutical merchandise with important market doable in China within the self-discipline of oncology; offering atmosphere friendly salvage correct of entry to for American biomedical corporations to enter into the Chinese language market; and aiming to bring the latest and most efficient medicines all one of the significant top ways by the globe to the Chinese language people. For more recordsdata, focus on with www.apollobio.com.
Forward-Taking a witness Statements
This press release contains sure forward-having a witness statements touching on to our industrial, together with the aptitude of VGX-3100 for the medication of cervical dysplasia, together with the reproducibility of the medical trial results in any future trials and the success of any future regulatory submission; the aptitude of INOVIO’s DNA remedy platform in HPV-related ailments; our ability to keep and retain development partnerships; and our expectations referring to future milestone or royalty funds. Accurate events or results may well presumably vary from the expectations do of dwelling forth herein on memoir of a assortment of things, together with uncertainties inherent in pre-medical analysis, medical trials, product development applications and commercialization actions and outcomes, the availability of funding to red meat up continuing analysis and analysis so as to expose safety and efficacy of electroporation know-how as a supply mechanism or invent viable DNA medicines, our ability to red meat up our pipeline of DNA remedy merchandise, the flexibility of our collaborators to achieve development and industrial milestones for merchandise we license and product gross sales that may enable us to receive future funds and royalties, the adequacy of our capital resources, the availability or doable availability of different therapies or treatments for the situations targeted by us or collaborators, together with choices that may be more efficacious or keep efficient than any therapy or medication that we and our collaborators hope to invent, factors intriguing product liability, factors intriguing patents and whether or not they or licenses to them will provide us with meaningful protection from others the employ of the covered applied sciences, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can face as a lot as claims of invalidity and whether we are able to finance or devote other important resources that may be critical to prosecute, give protection to or protect them, the stage of company expenditures, assessments of our know-how by doable company or other partners or collaborators, capital market situations, the impact of govt healthcare proposals and other factors do of dwelling forth in our Quarterly Document on Make 10-Q for the quarter ended March 31, 2026 and other filings we accomplish once rapidly with the Securities and Alternate Price. There is also no assurance that any product candidate in our pipeline would per chance be efficiently developed, manufactured, or commercialized, that the outcomes of medical trials would per chance be supportive of regulatory approvals required to market merchandise, or that any of the forward-having a witness recordsdata equipped herein would per chance be proven true. Forward-having a witness statements communicate simplest as of the date of this release, and we undertake no responsibility to update or revise these statements, with the exception of as would per chance be required by law.
INOVIO Contacts
Media: Jennie Willson, (267) 429-8567, [email protected]
Merchants: Peter Vozzo – ICR Healthcare, (443) 213-0505, [email protected]
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SOURCE INOVIO Prescribed medicine, Inc.
